Monthly Archives: September 2014

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Johnson & Johnson will buy South San Francisco’s Alios BioPharma
Inc. in a $1.75 billion cash deal that will boost the big
pharmaceutical company’s profile in hepatitis C and other virus
fighters.

The deal has been approved by the boards of both companies and is expected to close yet this year.

Partner Vertex Pharmaceuticals
Inc. (NASDAQ: VRTX) has an Alios-developed hepatitis C drug, called
ALS-2200 or VS-135, in mid-stage human studies, but Alios’ power for
J&J may rest deeper in the company’s portfolio. A number of drugs
that Alios is studying, as well as VS-135, tap into the hot area of
nucleotides.

PARIS (Reuters) – France will tax drugmakers whose costly hepatitis C
drugs threaten to throw off course its healthcare budget, the
government has said, heaping pressure on pharmaceutical companies like
Gilead Sciences to cut their prices.

The Socialist government said
it had designed a “progressive contribution scheme” ensuring all
patients can access new and more effective treatments against the
liver-destroying virus, while limiting the burden of these drugs on
state finances.

The government will selectively tax drugmakers
when the total cost to the state from their hepatitis C drugs exceeds a
certain amount each year, Health Minister Marisol Touraine said, as she
unveiled the country’s 2015 social security budget bill on Monday.

As this country plays catch-up with the other
industrialized nations that make health insurance available to
everyone, a lot of people are getting coverage for the first time.
Unfortunately, the health plans being offered today are complicated;
they are virtually all Managed Care Plans. Also, unlike countries that
cover everyone under one plan, our health coverage is handled primarily
through health insurance companies so there are major differences in
coverage and what an insured person is expected to pay out-of-pocket.

Managed Care Plans attempt to
direct a person’s health care in a way that will be more cost efficient
yet still provide quality medical care. How well they succeed with
those goals is regularly questioned, but for us, as consumers, we have
little choice.

These plans guide health care by
limiting when and how we access medical providers as well as who. They
also guide us through plan design as to how much they pay and how much
they ask us as the insured person to pay out of our pocket.

While it appears that the growth
of Managed Care Plans is helping to slow the growth in medical costs,
the design of these plans requires us as insured members to take a more
active role in our care and treatment choices.

On the market today, whether it
is through government insurance exchanges or through private agents and
companies, there are three primary types of Managed Care health plans,
HMOs, EPOs, and PPOs.

HMO (Health Maintenance Organization) – This
type of health plan has been around for several years. The main
feature is the requirement that it will only cover medical costs when
the member uses medical providers (doctors, laboratories, hospitals,
etc.) that have signed a contract with the HMO to become a Network
Provider. Except for charges related to a life threatening emergency,
they do not pay anything for treatment performed Out-of-Network.

The distinctive feature of an
HMO is that all care must go through a designated Primary Care
Physician (PCP), appropriately nicknamed “The Gatekeeper.” If you have a
rash and need to see a dermatologist, you must first go to your PCP
who will refer you to a panel dermatologist, assuming the Gatekeeper
agrees that you should see one or it is a simple enough issue that he
or she can provide the necessary salve or medication. The same would
usually apply to a person with HCV who needs to see their specialist.

NOTE: Some HMOs
will work with their members who are dealing with a chronic condition.
For example, they may name a PCP for a member dealing with HCV, but
will allow a “permanent” referral so the member can go directly to the
specialist who will treat the HCV and function as the PCP on other
medical issues.

EPO (Exclusive Provider Organization) – EPOs
are similar to HMOs with one major exception, they do not require a
Primary Care Physician or Gatekeeper. If a member wants to see a
dermatologist, he or she finds one on the list of Network Providers and
makes the appointment.

Other than that, they are similar to HMOs. You must use a Network provider to get any coverage.

There are a couple of areas where HMOs and EPOs are similar:

Emergency Care – As
mentioned, either type of plan would cover you if you went to an
Out-of-Network Emergency Room for a life-threatening emergency. In most
jurisdictions, courts have ruled that “life-threatening” means as it
appears to a lay person, not a physician. A person who goes to an ER
with chest pains should have coverage whether it’s a heart attack or
simply a bad stomach ache.

Choice of Providers –
Almost all HMOs and EPOs contract with large groups of providers who
work under a corporate structure. In addition, rather than sign
contracts with individual physicians in independent offices, physicians
and other providers will form an Independent Practice Association
(IPA) and the plan will contract with that umbrella group.

Rather than being able to see any
provider in a plan’s Directory, you will be limited to the medical
group or IPA in which you enrolled at the time of enrollment.

Preferred Provider Organization (PPO) – This
type of plan provides greater flexibility in the choice of
providers—unfortunately at the cost of a higher premium. Under a PPO
plan, the plan will pay a benefit regardless of which provider is used;
however, it will pay more of the medical bill if you use a Network
Provider than an Out-of-Network one. A typical plan will pay 80% if you
go to a Network Provider, but only 60% if using an Out-of-Network
Provider.

A PPO plan “manages” your care
through encouraging you to use their Network providers by paying more
of the bill. While you can choose a Primary Care Physician from the
Network if you wish, you have the right to see a specialist or other
physicians in or out of the Network. Obviously, it is to your advantage
financially to use Network Providers whenever possible.

NOTE: Keep in
mind physicians don’t keep track of which providers are in the PPO
Network. When a doctor refers you to another physician or sends out to a
laboratory, you should always specify that he or she should only refer
you to Network providers including hospitals and laboratories.

What Do I Pay?
As noted earlier, health plans vary greatly, yet
there is no plan that will pay all of the medical bills. However, the
amount an insured person must pay out-of-pocket falls into several
areas that a plan may or may not have in its schedule.

Deductible – This
is the amount of money and insured person is expected to pay before
the insurance company makes a payment. Sometimes, the deductible must
be paid before the carrier pays anything, other than for preventive
services. Sometimes the deductible only applies to certain medical
charges such has hospital charges or prescription medications.

Deductibles accumulate on a calendar year basis. After each January 1, a new deductible must be met.

Co-Pays – This
is the fee that is paid at the point of service. Some plans require you
to pay $10 to $25 each time you visit the doctor—sometimes even more
for specialists. Most plans charge a co-pay when you pick up a
prescription. NOTE: Ask for and keep a receipt of every co-payment in case questions arise later.

Co-Insurance – This
is the percentage of a covered medical bill that is paid by the
insurance company, leaving you to pay the remainder. Much more common
in PPO plans, this is the main reason to use only Network Providers in
PPO plans.

Network Providers have agreed to
limit what they charge for a procedure. If the PPO pays 80% of the
bill, then you are only obligated to pay the remaining 20%, regardless
of how much the doctor normally charges.

However, when you use an
out-of-Network provider, your plan is only obligated to pay its
percentage of the “usual, reasonable, and customary charge” for that
procedure. Of course, this is often less than what the doctor is
billing. In that case, you would be obligated to pay not only your
percentage under Co-Insurance, but also the amount in excess of what the
insurance company deemed “Reasonable.”

Out-of-Pocket Limit – Under the new
healthcare law, every health plan must limit the amount of money an
insured person can pay in any one calendar year for his or her portion
of the covered charges. At present the out-of-pocket limit cannot
exceed $6,350 for an individual or $12,700 for a family. While this may
seem high, such a limit on an insured person’s payment is far better
than having to pay 20% of a $200,000 hospital bill, which is not that
large of a bill today.

Preventive Services – The
new health care law also requires that all health insurance plans
cover preventive services at 100% with no deductible or co-pay. This
list currently includes over 50 services for adults, women, and
children. You can find a complete list at: https://www.healthcare.gov/what-are-my-preventive-care-benefits/

Regardless of which type of health insurance you
have, it is very important that you actively participate in your health
care and not rely on your doctor’s recommendations without question.

Thanks to sites like the HCV
Advocate and others on the web, there is a lot of information about
hepatitis C and its treatment. Thanks to the Internet, you can stay
current on new treatments, clinical trials, and new diagnostic methods.
It would be nice if everyone could find a physician whose practice
consisted only of HCV patients, but that is not possible. But you can
become one of your physician’s sources of new information about HCV
treatments and trials.

You should feel free to print out
information, cut out articles and take them to your physician.
Hopefully, he or she is already current, but you may be providing new
information. If your doctor is not the type that welcomes such input
from the patient, you may be seeing the wrong doctor.

Find a doctor knowledgeable in HCV. This
is true whether you are in an HMO and must have a “Gatekeeper” or
finding a doctor in an EPO or PPO network to visit regularly.

However, the Network directories
of providers will give you only minimal information about your choices,
and it won’t tell you which PCPs frequently treat patients with HCV or
stay current about it. Clearly, you will need to do some research.

If you attempt to call the
Managed Care Plan itself, they will not provide much information, as
they are prohibited from “steering” patients to particular clinics or
doctors, even if it would mean better health care.

Gastroenterology is the specialty
that many people use. If available, you may also use a
hepatologist—who may be more knowledgeable about HCV. If you wish, call
several doctors’ offices to learn more. Some questions you may want to
ask include:

Does the doctor treat other patients with HCV?

Does he stay current on HCV
treatments? Do not hesitate to ask very specific questions,
referring to treatments and using terms you have learned in your
research on HCV. If they don’t know what you’re talking about,
scratch them off your list and move on.

Who are the
gastroenterologists, hepatologists, infectious disease
specialists, or other HCV knowledgeable specialists that the
doctor works with and refers patients to?

The days are long gone in any healthcare delivery
system when patients could put themselves in the doctor’s hands and
rest assured that they were getting the best and latest treatment.
However, in Managed Care systems, it becomes even more important that
you stay actively involved in your medical care. To do that, you must
find knowledgeable medical providers who not only know about HCV, but
who will listen to you and answer questions candidly when determining
the direction of your care.

Excitement is growing ahead of the Food and Drug Administration’s decision on Gilead Sciences (NASDAQ: GILD )
next generation hepatitis C treatment. Most expect that the regulator
will give the Sovaldi and ledipasvir combination drug the green light
when it makes its decision on October 10, but Gilead isn’t sitting back
on its heels waiting. The company announced this week that it’s also
submitted the Sovaldi and ledipasvir one-drug therapy for approval in
Japan, one of the globe’s biggest markets for hepatitis C treatment.

The move is an important one because it could ultimately allow Gilead to erase Bristol Myers (NYSE: BMY ) early lead in that market, potentially giving Gilead an opportunity to capture billions of dollars in sales.

Bristol’s decision to file for approval first in Japan gives it an early lead
over Gilead, which focused on the U.S. and America instead. But if
Japan approves the Gilead and ledipasvir combination, that lead may fade
quickly.

“Had there been more oversight, we would have learned from the first
time that people got infected with Hepatitis C and made sure it did not
happen in other clinics.”

New Democrat Health and Long-Term Care critic France Gelinas is
calling for a moratorium on the creation of new private health-care
clinics and more downloading of hospital services into the community
after infectious outbreaks at private clinics in Toronto.

The Nickel Belt MPP said she doesn’t want the province to allow the
establishment of new private clinics until layers of oversight are in
place to guarantee proper care and safety for the patients who visit
them.

Gelinas has been making headlines after a Toronto newspaper broke
stories about nine people becoming infected with life-threatening
bacterial infections, including meningitis, and three private
colonoscopy clinics having hepatitis outbreaks since 2011.

Family
nurse practitioner Laura Bush helped Richard Davis, who had hepatitis
C, get a new two-drug, 12-week treatment that cured him of the disease,
but also cost $180,000.

Richard Davis hit a low point early this year after his insurance
company denied him coverage for an effective new therapy for hepatitis
C, a viral illness that damaged his liver and caused him constant pain.

“I have known people who died of (hepatitis C) and it’s not a pleasant death,” Davis, 57, told the Journal, saying his diagnosis with the disease in 2013 left him stunned. “I knew what was coming.”

Davis also knew that he couldn’t pay the huge cost of the two-drug treatment he needed.

Healio.com/Hepatology has compiled a list of the latest, most
relevant research on hepatitis C virus infection presented recently at
ICAAC 2014 in Washington, D.C.

PEARL-II, III: High SVR rates met in HCV genotype 1b patients

A majority of patients with hepatitis C virus infection
genotype 1b achieved sustained virologic response at 12 weeks during
treatment with a three direct-acting antiviral regimen with or without
ribavirin. Read more

Hospitalization rates increased for patients with HCV, diabetes

An epidemiologic study based on a
retrospective survey of data from the National Spanish System for
Hospital Data between 1997 and 2010 was performed to determine the
number of people hospitalized with hepatitis C virus and diabetes.
Researchers said the number of patients hospitalized and coinfected
with HCV and diabetes in Spain increased during a 14-year period.

“The development of preventive, diagnostic and
therapeutic guidelines directed toward the control of glycemia and the
reduction of insulin resistance in HCV-positive patients may help to
reduce the hospital burden of the disease,” the researchers wrote. Read more

The study is aimed at assessing the safety and immunogenicity of HCV prime-boost vaccinations ChAd3-hliNSmut and MVA-hliNSmut, administered intramuscularly in healthy volunteers and DAA treated patients. To read the entire study, click here Share This PageFollow Us … Continue reading → The post The study is aimed at assessing the safety and immunogenicity of HCV […]

The purpose of this study is to evaluate the efficacy and tolerability of DAA-based regimens in the clinical practice in HIV/HCV-coinfected patients. Hypothesis: The efficacy and tolerability of all DAA-based regimens in the clinical practice is different to what is … Continue reading → The post Real-life Security and Efficacy of DAA-based Therapy in 1,000 […]